Myoelectric Upper Limb Orthosis Use by Persons With TBI and Stroke

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT03215771
Collaborator
Louis Stokes VA Medical Center (U.S. Fed), Myomo Inc. (Other)
16
1
1
42.3
0.4

Study Details

Study Description

Brief Summary

The objective of this study was to document longitudinal outcomes in persons with traumatic brain injury (TBI) or stroke using the myoelectric upper limb orthosis with powered elbow and grasp in conjunction with motor learning-based therapy using both patient centric performance and patient reported outcome measures. Longitudinal observation allowed the investigators to detect both the initial therapeutic effects as well as the later functional outcomes of orthosis use. The investigators planned to recruit 15 Veterans and non-veterans who had TBI or stroke and upper limb impairment. The study required 29 visits over 22 weeks and was divided into three parts: orthotic fitting, therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits were evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.

Condition or Disease Intervention/Treatment Phase
  • Device: MyoPro Motion-G
  • Other: Motor Learning-Based Therapy
N/A

Detailed Description

This study had two aims: (1) to evaluate therapeutic and neuroplastic effects of a myoelectric upper limb orthosis in conjunction with motor learning-based therapy and (2) to evaluate the functional effects of a myoelectric upper limb orthosis in conjunction with motor learning-based therapy. The investigators planned to recruit 15 Veterans and non-veterans who had Traumatic Brain Injury (TBI) or stroke and upper limb impairment, were over 18 years of age and a minimum of 6 months from injury. The study required 29 visits over 22 weeks and was divided into three parts: orthotic fitting, therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits were evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.

Subjects were enrolled in the study if they met eligibility criteria assessed at a screening visit. Once enrolled subjects were fit with a custom fabricated MyoPro Motion-G elbow-wrist-hand orthosis following standard clinical procedures. This process required up to three visits to cast, trial fit and deliver the orthosis. Subjects then participated in a standard-of-care motor learning based therapy protocol in conjunction with the PERL ("Push Eat Reach Lift") training program recommended by Myomo, which consists of a 9 week, 18 session training plan. Every second week, there was one session that combined therapy/training and outcomes evaluation.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Longitudinal Observation of Myoelectric Upper Limb Orthosis Use Among Veterans With Upper Limb Impairment
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Jun 12, 2020
Actual Study Completion Date :
Jun 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: MyoPro + Motor Learning-Based Therapy

Subjects received 9 weeks of motor learning-based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program.

Device: MyoPro Motion-G
The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.

Other: Motor Learning-Based Therapy
Motor learning-based (MLB) therapy included movement practice as close to normal as possible, high repetition, progression of challenge, part versus whole task practice, and knowledge of results. Treatment was customized to abilities of each subject and consisted of both MyoPro training and MLB therapy without device. Training with device was progressed using a hierarchy of challenge to increase complexity of movement. MLB therapy without device followed the same hierarchy, incorporating training of movements that could not be accomplished with the device and those that were trained with device. Movement quality was monitored and training practice was incrementally progressed as subject demonstrated improved ability to perform a given task/movement component. Subjects performed a custom home exercise program (HEP) on non-clinic days, increasing repetition as tolerated. At conclusion of in-clinic phase, individuals transitioned to a home phase where they continued to use the HEP.

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) [Change in Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) from Baseline at Week 18]

    Evaluation of motor impairment of the upper limb. Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points total) where higher scores represent less arm impairment.

Secondary Outcome Measures

  1. Modified Ashworth Scale [Change in Modified Ashworth Scale from Baseline at Week 18]

    Using a 6-point scale, the clinician evaluates resistance to passive movement about a joint with varying degrees of velocity as follows: 0 No increase in muscle tone. 1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension. 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM. 2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3 Considerable increase in muscle tone, passive movement difficult. 4 Affected part(s) rigid in flexion or extension. A lower score represents less resistance to passive movement.

  2. Chedoke Arm and Hand Activity Inventory (CAHAI) [Change in Chedoke Arm and Hand Activity Inventory (CAHAI) from Baseline at Week 18]

    Used to assess performance of activities of daily living (ADLs). Measure consists of 13 functional tasks scores and the score for each functional task are summed to compute the total score. Scoring of each task is based on a 7-point scale (1=unable; 7=normal performance; minimum score is 13 points; maximum score is 91 points), where higher scores represent better performance of ADLs.

  3. Orthotic and Prosthetic Users' Survey Satisfaction Module (OPUSsat) [Change in Orthotic and Prosthetic Users' Survey satisfaction module (OPUSsat) from Baseline at Week 18]

    An 11-item patient-reported survey that assesses satisfaction with device using a 5-point Likert scale. Satisfaction with device is the sum of the scores (score range: 11-55), where higher scores indicate better satisfaction with device.

  4. Craig Handicap Assessment and Rehabilitation Technique (CHART) [Change in Craig Handicap Assessment and Rehabilitation Technique (CHART) from Baseline at Week 18]

    A life-role participation survey measuring the level of handicap using objectively observable behaviors in five dimensions: physical, social, cognitive, mobility, and occupation. Survey responses are combined using formulas for each domain. The score in each domain is capped at 100 (total score range: 0-500). Higher scores represent better self-reported participation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • over 18 years of age

  • minimum 6 months since injury

  • elbow, forearm, wrist and hand have full motion with little resistance from muscles when moved by someone else

  • some ability to actively move the shoulder

  • able to generate consistent and detectable electrical signals from the upper arm and forearm muscles

  • able to read and comprehend the English language

  • able to follow two-stage command

  • cognitive abilities sufficient to perform testing and training protocols

  • able to tolerate functional tasks for 60 minutes without excessive fatigue

  • medically and psychologically stable

  • at home support from a family member or care giver if needed

Exclusion Criteria:
  • elbow, forearm, wrist and hand have less than full motion with high resistance from muscles when moved by someone else

  • shoulder instability, pain or dislocation

  • unable to safely support the weight of arm with added weight of the device without pain

  • less than 12 weeks since botulinum toxin injection in the impaired arm

  • new therapies/medications planned during study period

  • skin rash or open wound on impaired arm

  • inability to detect light touch or pain on impaired arm

  • involuntary movements of the impaired arm

  • pain or hypersensitivity in the impaired arm

  • inability to understand English

Contacts and Locations

Locations

Site City State Country Postal Code
1 Louis Stokes Cleveland VA Medical Center Cleveland Ohio United States 44106

Sponsors and Collaborators

  • Northwestern University
  • Louis Stokes VA Medical Center
  • Myomo Inc.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Stefania Fatone, PhD, BPO(Hons), Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT03215771
Other Study ID Numbers:
  • W81XWH-16-1-0733
First Posted:
Jul 12, 2017
Last Update Posted:
Jul 15, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title MyoPro + Motor Based Learning
Arm/Group Description Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Period Title: Overall Study
STARTED 16
Stroke Subjects 8
TBI Subjects 8
COMPLETED 13
NOT COMPLETED 3

Baseline Characteristics

Arm/Group Title MyoPro + Motor Based Learning
Arm/Group Description Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program. MyoPro Motion-G: The MyoPro Motion-G is a custom-fabricated elbow-wrist-hand myoelectric orthosis.
Overall Participants 13
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
50.62
(19.91)
Sex: Female, Male (Count of Participants)
Female
8
61.5%
Male
5
38.5%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome
Title Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA)
Description Evaluation of motor impairment of the upper limb. Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points total) where higher scores represent less arm impairment.
Time Frame Change in Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) from Baseline at Week 18

Outcome Measure Data

Analysis Population Description
combined results from 6 TBI and 7 stroke subjects
Arm/Group Title MyoPro + Motor Based Learning
Arm/Group Description Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use of the MyoPro along with a home exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Measure Participants 13
Mean (95% Confidence Interval) [score on a scale]
7.5
2. Secondary Outcome
Title Modified Ashworth Scale
Description Using a 6-point scale, the clinician evaluates resistance to passive movement about a joint with varying degrees of velocity as follows: 0 No increase in muscle tone. 1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension. 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM. 2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3 Considerable increase in muscle tone, passive movement difficult. 4 Affected part(s) rigid in flexion or extension. A lower score represents less resistance to passive movement.
Time Frame Change in Modified Ashworth Scale from Baseline at Week 18

Outcome Measure Data

Analysis Population Description
combined results from 6 TBI and 7 stroke subjects
Arm/Group Title MyoPro + Motor Based Learning
Arm/Group Description Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Measure Participants 13
Mean (95% Confidence Interval) [score on a scale]
-2.3
3. Secondary Outcome
Title Chedoke Arm and Hand Activity Inventory (CAHAI)
Description Used to assess performance of activities of daily living (ADLs). Measure consists of 13 functional tasks scores and the score for each functional task are summed to compute the total score. Scoring of each task is based on a 7-point scale (1=unable; 7=normal performance; minimum score is 13 points; maximum score is 91 points), where higher scores represent better performance of ADLs.
Time Frame Change in Chedoke Arm and Hand Activity Inventory (CAHAI) from Baseline at Week 18

Outcome Measure Data

Analysis Population Description
combined results from 6 TBI and 7 stroke subjects
Arm/Group Title MyoPro + Motor Based Learning
Arm/Group Description Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Measure Participants 13
Mean (95% Confidence Interval) [score on a scale]
8.8
4. Secondary Outcome
Title Orthotic and Prosthetic Users' Survey Satisfaction Module (OPUSsat)
Description An 11-item patient-reported survey that assesses satisfaction with device using a 5-point Likert scale. Satisfaction with device is the sum of the scores (score range: 11-55), where higher scores indicate better satisfaction with device.
Time Frame Change in Orthotic and Prosthetic Users' Survey satisfaction module (OPUSsat) from Baseline at Week 18

Outcome Measure Data

Analysis Population Description
combined results from 6 TBI and 7 stroke subjects
Arm/Group Title MyoPro + Motor Based Learning
Arm/Group Description Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Measure Participants 13
Mean (95% Confidence Interval) [score on a scale]
26.7
5. Secondary Outcome
Title Craig Handicap Assessment and Rehabilitation Technique (CHART)
Description A life-role participation survey measuring the level of handicap using objectively observable behaviors in five dimensions: physical, social, cognitive, mobility, and occupation. Survey responses are combined using formulas for each domain. The score in each domain is capped at 100 (total score range: 0-500). Higher scores represent better self-reported participation.
Time Frame Change in Craig Handicap Assessment and Rehabilitation Technique (CHART) from Baseline at Week 18

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title MyoPro + Motor Based Learning
Arm/Group Description Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Measure Participants 13
Mean (95% Confidence Interval) [score on a scale]
34.9

Adverse Events

Time Frame 18 weeks
Adverse Event Reporting Description
Arm/Group Title MyoPro + Motor Based Learning
Arm/Group Description Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
All Cause Mortality
MyoPro + Motor Based Learning
Affected / at Risk (%) # Events
Total 0/13 (0%)
Serious Adverse Events
MyoPro + Motor Based Learning
Affected / at Risk (%) # Events
Total 0/13 (0%)
Other (Not Including Serious) Adverse Events
MyoPro + Motor Based Learning
Affected / at Risk (%) # Events
Total 0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Stefania Fatone, Principle Investigator
Organization Northwestern University
Phone 3125035717
Email s-fatone@northwestern.edu
Responsible Party:
Stefania Fatone, PhD, BPO(Hons), Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT03215771
Other Study ID Numbers:
  • W81XWH-16-1-0733
First Posted:
Jul 12, 2017
Last Update Posted:
Jul 15, 2021
Last Verified:
Jul 1, 2021